Summary

Eligibility
for people ages 18-80 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

Summary

Background. Abdominal distention is produced by an abnormal somatic postural tone. The authors developed an original biofeedback technique. In a randomized, placebo-controlled trial the authors demonstrated the superiority of biofeedback over placebo for the treatment of abdominal distention. However, the technique is technically complex and unpractical.

Aim. To prove the efficacy of a noninstrumental biofeedback technique, transmitted by a standard training program, for the treatment of abdominal distension in different centers.

Selection criteria. Episodes of visible abdominal distension. Intervention. Patients will be randomized into biofeedback and placebo groups. Three sessions of either biofeedback or placebo intervention will be performed during the first 3 weeks of the intervention period.

Biofeedback: Patients will be taught to control abdominal and thoracic muscular activity by providing instructions using an original video support. In each center one operator will receive a standard training on how to deliver the noninstrumental biofeedback treatment. Patients will be instructed to perform the same exercises before and after breakfast, lunch and dinner during the 4-week intervention period.

Placebo: Sham measurements of abdominal and thoracic motion will be performed, and a pill of placebo containing 0.21 g glucose will be administered; patients will be instructed to take a pill of placebo before breakfast, lunch and dinner during the 4-week intervention period.

Official Title

Tratamiento de la distensión Abdominal Funcional

Keywords

Irritable Bowel Syndrome, Dyspepsia, Functional Bloating, Biofeedback

Eligibility

You can join if…

Open to people ages 18-80

  • episodes of visible abdominal distension triggered by meal ingestion

You CAN'T join if...

  • organic cause detected by clinical work-up
  • constipation
  • abdominal distension not confirmed by the 7-day clinical questionnaires in the pre- intervention evaluation

Locations

  • G. Oppenheimer Center for Neurobiology of Stress and Resilience
    Los Angeles California 90095 United States
  • McMaster University
    Hamilton Ontario ON L8S 4L8 Canada

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
ID
NCT06369753
Study Type
Interventional
Participants
Expecting 100 study participants
Last Updated